FDAJune 19, 2018device

AnastoClip GC Closure System, REF# 4007-08 a closure system designed to penetrate the outer layers of tissue during the forming of an anastomosis or closing of a vessel with possible intraluminal penetration.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The wrong instructions for use (IFU) were supplied with the AnastoClip GC closure system. The IFU provided lists some indications which are not cleared by the FDA for devices distributed in the United States: 1) closure of arteriotomies and veinotomies, 2) attachment of synthetic vascular prostheses, and 3) approximation of dural tissue.

What to do

FDA enforcement status: Terminated

Brands named

lemaitre vascularlemaitre

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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